A biobank is a type of biorepository that stores biological samples (usually human) for use in research.
Where are biological samples coming from?
Biological samples (or biospecimens) in these collections are taken for diagnostic purposes and, according to the official regulations, they are stored even after the establishment of diagnosis. Most of these biospecimens are collected during routine clinical and surgical procedures. They are called “residual human corporate materiel”.
Donating samples to a biobank can also be voluntary. During a hospital visit, a patient can be asked whether he or she would be interested in donating his or her samples to the hospital’s biobank for a specific research. The potential sample donors will receive detailed information about biobank research and data privacy issues, after which they can decide whether to donate their samples. Sample donors can also at any time withdraw their consent and prohibit further use of their samples.
Scientific biobanks are indispensable for scientific investigation and study of certain disorders and biologic phenomenon.
In the modern biobanks, tissue samples are stored and conserved in several different ways in order to perform as many analyses as possible. An integral part of scientific biobanks is the clinical database with detailed data about the general health condition, medical history, progression of disease and treatment, etc…. The discoveries and observations may be interpreted only in the possession of these data.
Biobanks give researchers access to data representing a large number of people. Samples in biobanks and the data derived from those samples can often be used by multiple researchers for cross purpose research studies.
Biobanks have emerged as a significant research tool, gaining support from both the scientific community and regional, national and international research funding agencies.
How are the data protected?
The privacy of biobank participants' information is protected by removal of personal identifiers before data are made available to researchers. Removing fields that include names, addresses, birthdates, ages, phone and fax numbers, driver's license and identification numbers, URLs, IP and email addresses, photographs, fingerprints, and other biometric identifiers is often viewed as an effective de-identification of data.
To protect the professional interests of scientists and the rights of research participants, biobanks are increasingly making use of a variety of access agreements. Usually some of the data from the biobank (a limited amount of de-identified clinical data annotation fields) will be made available to researchers while the more sensitive data and samples, if accessible at all, will be made available only to researchers who agree to comply with the strict terms of these access agreements.
Why do we need biological samples?
Biospecimens such as blood, surgical tissue, saliva, and urine contain genetic material that researchers analyze to identify gene variations associated with human diseases. By identifying the role that genes play in disease formation, researchers may be able to develop new diagnostic tests and targeted treatments for specific diseases and to investigate how genes interact with environmental factors. This research may also open the way to “personalized medicine”—treatments that are customized to a person’s genetic profile.
What is the 'consent'?
There is international consensus that for most research with humans to be ethical, at least two key requirements must be met: an ethical committee must review and approve a study before researchers recruit participants, and participants must voluntarily consent to be in the study. In other instances, individuals may have given consent for specific types of research with their biospecimens, but later on researchers want to use them for other types of studies. The Belgian BioBank has a process that lets researchers recontact individuals to obtain consent for new research with their stored biospecimens as the need arises.
Sometimes, stored biospecimens were collected for purposes other than research, for example during routine clinical and surgical procedures. In this case, individuals did not give consent for those biospecimens to be used in research but the Belgian law has adopted what we call the “presumed consent”: research based solely on this residual human corporal materiel can proceed based on the approval by the ethical committee and the fact that the patient/donor did not oppose. Of course, the patient has the right to oppose to the use of this residual human corporal materiel for research by simply letting this known to the hospital, without any justification.
What is an 'ethical committee'?
The members of the Ethical Committee come from a wide variety of medical and non-medical fields: such as doctors, nurses, social workers, ethicists, lawyers…
They safeguard the rights, safety, dignity and well-being of research participants, independently of research sponsors.
Why an 'ethical committee'?
The purpose of ethics review is to ensure that persons independent of the research determine that the study’s potential benefits to participants outweigh the potential risks of research participation. The informed consent rule is to ensure that individuals who enroll in a study understand its purpose and voluntarily agree to expose themselves to potential research risks.
Are the research results published?
Not all research results are published, and even those that are usually appear long after the study began and in specialized science journals. Thus, people who provide biospecimens for research—along with the general public—might never learn the outcome of that research. There are reasons for not disclosing some findings. Preliminary or inconclusive results might not have clinical value and could provide misleading information about the causes of disease, especially when the research involves analysis of genetic materials. Genetic research results have privacy implications for family members who did not provide biospecimens for research.
Despite these concerns support is growing for the principle that researchers and study sponsors have an obligation to disclose both positive and negative research results, provided that certain conditions are met. Yet how and when to do this remains unclear. Some international medical and scientific working groups recommended that researchers disclose results of genetic studies when the associated risk for the disease is significant, when the disease has important health or significant reproductive implications, and when proven therapeutic or preventive interventions are available.